D.C. Week: SCOTUS Reignites Obamacare Contraception Debate

WASHINGTON -- In the nation's capital this week, the Supreme Court asked a lower court to re-evaluate its decision to back the Obamacare contraception mandate, winning applause from religious conservatives, while a House subcommittee pushed on the so-called 21st Century Cures initiative.

Also this week, the Office of the Inspector General in the Department of Health and Human Services reminded states that monies given to establish their health insurances exchanges can't be spent on operations, and the Centers for Medicare and Medicaid Services (CMS) found that Medicare Part D patient costs are roughly equal whether they visit internists or family doctors.

On Monday, the Supreme Court rekindled religious groups' efforts to eliminate the Obamacare contraception mandate when it scrapped a lower court's decision to back the federal government, according to The Hill. The provision requires employers to include birth control costs with first-dollar coverage in their employee health plans.

Following the Supreme Court's own ruling this past June, which exempted specific private corporations from the mandate, the justices told the 6th U.S. Court of Appeals in Cincinnati to revisit a lawsuit filed by Catholic ministries in Michigan and Tennessee, in which the lower court ultimately sided with the Obama administration.

House Subcommittee Presses Forward on 21st Century Cures

Roughly 95% of rare diseases have no FDA-approved treatment. Congress hopes that by equipping government agencies with better resources, it can accelerate innovation and bring cures to patients faster.

The latest draft of the 21st Century Cures bill would grant $10 billion in mandatory funding to the National Institutes of Health beginning in fiscal year 2016.

"The research committee is ecstatic to see this new provision in the bill, and we are deeply appreciative," said Kathy Hudson, PhD, deputy director for Science, Outreach, and Policy at the NIH.

Among the roughly 105,000 family physicians included in the data, the average cost per provider was $211,977, compared with an average cost of $205,923 for approximately 131,000 internists, the data showed. The prescribing data are broken down by individual provider.

The data release, which will occur annually, is part of an ongoing effort at the agency to increase its transparency, Sean Cavanaugh, director of the Center for Medicare at CMS, told reporters on a conference call. "This transparency helps empower patients, researchers, and providers so they know more about the Medicare program."

OIG: States Can't Use Exchange Startup $ for Operations

States, take notice: the federal government is watching how you spend the start-up grant money for your state-based health insurance exchange. That's the message from an "early alert" posted Wednesday by the Office of Inspector General (OIG) at the Department of Health and Human Services.

"Starting in January 2015, establishment grant funds provided by the Centers for Medicare and Medicaid Services (CMS) to the SBMs [state-based marketplaces] cannot be used for operational costs," the OIG noted in the alert, which was sent to CMS acting administrator Andy Slavitt. "We have concerns that, without more detailed guidance from CMS, SBMs might have used, and might continue to use, establishment grant funds for operating expenses after Jan. 1, 2015, contrary to law. This issue is a significant matter and requires CMS's immediate attention."

Double-Chin Fat Dissolver OK'd

An injection to reduce accumulations of submental fat -- better known as double chin -- is safe and effective and can be marketed for the indication, the FDA said Wednesday.

To be sold as Kybella, the synthetic deoxycholic acid agent was developed by Kythera Pharmaceuticals of Westlake Village, Calif.

Deoxycholic acid is an endogenous substance that, in normal physiology, helps the body absorb fat. When injected into tissues it dissolves cell membranes.

Under current rules, any product can be marketed as antiseptic if it contains ingredients listed in a 1994 FDA monograph on such products, which included a number of agents generally recognized both as effective in killing pathogens and as safe for topical use. These ranged from various alcohols and iodine tinctures to triclosan and hexylresorcinol.

But since then, the FDA said in announcing the new proposal, "many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA's safety standards, and the scientific knowledge about the impact of widespread antiseptic use."

Next Week

On Tuesday, the Senate Health, Education, Labor and Pension Committee will discuss the Precision Medicine initiative.

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